10 Participants Needed

HIPEC during Surgery for Ovarian Cancer

(HIPEC Trial)

SN
Overseen ByStudy Nurse
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Wake Forest University Health Sciences
Must be taking: Platinum chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it does require that you have completed a specific course of platinum-based chemotherapy before participating.

What data supports the effectiveness of the treatment HIPEC during surgery for ovarian cancer?

Research shows that combining surgery with heated chemotherapy (HIPEC) can be effective for treating cancers in the abdomen, including ovarian cancer, especially in patients who have not responded well to other treatments. This approach has been used successfully in other types of abdominal cancers, suggesting it may help improve outcomes for ovarian cancer patients as well.12345

Is HIPEC during surgery for ovarian cancer generally safe for humans?

HIPEC, when combined with surgery, has been associated with significant risks, including long hospital stays and moderate risk of death around the time of surgery. However, some studies suggest that these risks can be reduced with experience and careful management.12567

How is the HIPEC treatment with carboplatin during surgery for ovarian cancer different from other treatments?

HIPEC with carboplatin is unique because it involves delivering heated chemotherapy directly into the abdominal cavity during surgery, which can enhance the drug's effectiveness against cancer cells compared to traditional intravenous chemotherapy.148910

What is the purpose of this trial?

The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' health.

Research Team

LB

Laurel Berry, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults over 18 with specific types of ovarian, fallopian tube, or peritoneal cancer. Participants must have completed certain surgeries and chemotherapy within a set timeframe, have no current evidence of disease, and meet specific health criteria like organ function. Pregnant individuals or those with recent infections, severe allergies to carboplatin, or unstable health conditions are excluded.

Inclusion Criteria

Ability to understand and the willingness to sign an IRB-approved informed consent document
I show no signs of cancer after chemotherapy, confirmed by exams and tests.
My surgery removed all visible cancer before starting chemotherapy.
See 6 more

Exclusion Criteria

You have had allergic reactions to drugs similar to carboplatin.
Pregnancy
I have not had radiation therapy to my abdomen or pelvis.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo second look laparoscopy and may receive hyperthermic intraperitoneal chemotherapy (HIPEC) with carboplatin if visible signs of cancer are present.

Up to 3 months

Follow-up

Participants are monitored for quality of life and toxicities using the FACT-O questionnaire and CTCAE criteria.

Up to 6 months

Treatment Details

Interventions

  • Carboplatin
  • Second look laparoscopy reassessment surgery (SLLRS)
Trial Overview The study tests the feasibility and impact on quality of life when administering heated chemotherapy (HIPEC) during a second look laparoscopy surgery in patients who've had prior treatment for certain cancers. The FACT-O questionnaire will assess participants' quality of life outcomes.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Second Look Laparoscopy and HIPEC with CarboplatinExperimental Treatment3 Interventions
Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Paraplatin for:
  • Ovarian cancer
  • Testicular cancer
  • Lung cancer
  • Head and neck cancer
  • Brain cancer
🇪🇺
Approved in European Union as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
🇨🇦
Approved in Canada as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
  • Testicular cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study involving 122 patients undergoing 124 cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CS-HIPEC) procedures, the in-hospital mortality rate was nearly zero, and the 30-day mortality rate was only 1.6%, indicating a significant improvement in safety for this treatment approach.
Despite the low mortality rates, the study reported a high overall morbidity rate of 56.5%, with major complications occurring in 29.8% of cases, highlighting the need for further research to optimize patient outcomes in the treatment of peritoneal carcinomatosis.
Aggressive surgical management of peritoneal carcinomatosis with low mortality in a high-volume tertiary cancer center.Gusani, NJ., Cho, SW., Colovos, C., et al.[2022]
In a study of 15 patients with peritoneal carcinomatosis, the combination of cytoreductive surgery (CS) followed by intraperitoneal hyperthermic chemotherapy (IPHC) resulted in a median survival time of 8.4 months, which aligns with previous research findings.
The treatment was associated with significant surgical interventions, including bowel resections and blood transfusions, indicating a complex perioperative course, and highlights the need for further research to explore factors influencing survival and quality of life.
Cytoreductive surgery and intraperitoneal hyperthermic chemotherapy in the treatment of peritoneal carcinomatosis.Gammon, DC., Dutton, T., Piperdi, B., et al.[2019]
Cytoreductive surgery combined with intraperitoneal hyperthermic chemoperfusion (IHCP) shows a high risk of postoperative complications (44.3%), but with proper patient selection and care, most complications can be managed effectively.
Completeness of cancer resection and patient age are significant predictors of postoperative morbidity, highlighting the importance of thorough surgical techniques and careful patient assessment in improving outcomes.
Treatment of peritoneal carcinomatosis by cytoreductive surgery and intraperitoneal hyperthermic chemoperfusion (IHCP): postoperative outcome and risk factors for morbidity.Roviello, F., Marrelli, D., Neri, A., et al.[2022]

References

Aggressive surgical management of peritoneal carcinomatosis with low mortality in a high-volume tertiary cancer center. [2022]
Cytoreductive surgery and intraperitoneal hyperthermic chemotherapy in the treatment of peritoneal carcinomatosis. [2019]
Treatment of peritoneal carcinomatosis by cytoreductive surgery and intraperitoneal hyperthermic chemoperfusion (IHCP): postoperative outcome and risk factors for morbidity. [2022]
A Retrospective Clinical Analysis of Hyperthermic Intraperitoneal Chemotherapy in Gynecological Cancers: Technical Details, Tolerability, and Efficacy. [2022]
Reduced morbidity following cytoreductive surgery and intraperitoneal hyperthermic chemoperfusion. [2007]
Intraperitoneal hyperthermic chemotherapy using carboplatin: a phase I analysis in ovarian carcinoma. [2013]
Cytoreductive surgery followed by intraperitoneal hyperthermic perfusion: analysis of morbidity and mortality in 209 peritoneal surface malignancies treated with closed abdomen technique. [2022]
Secondary Cytoreduction and Carboplatin Hyperthermic Intraperitoneal Chemotherapy for Platinum-Sensitive Recurrent Ovarian Cancer: An MSK Team Ovary Phase II Study. [2023]
Results of a multicenter phase I dose-finding trial of hyperthermic intraperitoneal cisplatin after neoadjuvant chemotherapy and complete cytoreductive surgery and followed by maintenance bevacizumab in initially unresectable ovarian cancer. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Morbidity after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with carboplatin used for ovarian, tubal, and primary peritoneal cancer. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security